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The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.
In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10).
Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX102 Dose 1 | Experimental | LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0 |
|
| LX102 Dose 2 | Experimental | LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0 |
|
| Control group | Active Comparator | Aflibercept at a fixed regimen will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX102 subretinal injection | Genetic | LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in Best Corrected Visual Acuity (BCVA) | BCVA measured by ETDRS | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in Best Corrected Visual Acuity (BCVA) | BCVA measured by ETDRS | 52 weeks |
| Mean change in Central Subfield Thickness (CST) from Baseline | CST measured by spectral domain optical coherence tomography (SD-OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | China | |||
| Zhejiang University Eye Hospital |
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| Aflibercept intravitreal injection | Biological | Commercially available Active Comparator |
|
| 36 weeks, 52 weeks |
| Durability of LX102 treatment | Mean time from LX102 administration to anti-VEGF rescue injection for the first time, percentage of participants requiring anti-VEGF rescue injection, and mean number of anti-VEGF rescue injections through 52 weeks following LX102 administration. | 52 weeks |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection | 36 weeks, 52 weeks |
| Hangzhou |
| Zhejiang |
| China |
| Peking Union Medical College Hospital | Beijing | China |
| West China Hospital of Sichuan University | Chengdu | China |
| Guangzhou Aier Eye Hospital | Guangzhou | China |
| Zhongshan Ophthalmic Center of Sun Yat-Sen University | Guangzhou | China |
| Shanghai Eye and ENT Hospital | Shanghai | China |
| Shanghai General Hospital | Shanghai | China |
| Shanxi Eye Hospital | Taiyuan | China |
| Tianjin Medical University Eye Hospital | Tianjin | China |
| Xuzhou No.1 People's Hospital | Xuzhou | China |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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